UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016763 |
|---|---|
| Receipt number | R000019421 |
| Scientific Title | Efficacy study of the carbon ion radiotherapy in 16 fractions for castration refractory prostate cancer |
| Date of disclosure of the study information | 2015/03/15 |
| Last modified on | 2017/03/11 11:24:44 |
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Basic information
Public title
Efficacy study of the carbon ion radiotherapy in 16 fractions for castration refractory prostate cancer
Acronym
GUNMA1103
Scientific Title
Efficacy study of the carbon ion radiotherapy in 16 fractions for castration refractory prostate cancer
Scientific Title:Acronym
GUNMA1103
Region
| Japan |
Condition
Condition
castration refractory prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of the carbon ion radiotherapy in 16 fractions for non-metastatic castration refractory prostate cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-yr biochemical relapse free survival
Key secondary outcomes
1) 5-yr overall survival
2) 5-yr cause specific survival
3) 5-yr local control
4) acute toxicity
5) late toxicity
6) QOL
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Continuous PSA increase in spite of castration level of testosterone.
2) Histologically proven primary prostate adenocarcinoma
3) Gleason score is diagnosed
4) T1c-T3N0M0(2009, UICC 7th)
5) PSA value before biopsy and before this study are measured
6) No lymph node and distant metastasis
7) Age at registration is 20-80
8) Performance status is 0-2
9) Diagnosis is informed
10) Having the ability to consent
Key exclusion criteria
1) Past radiotherapy to the pelvic region
2) Past physical treatment of the prostate (TUR-P, HIFU, etc.)
3) Past chemotherapy within 4 weeks
4) Life expectancy is less than 6 months
5) Multiple malignancies within 5 years
6) Severe comorbidity
7) Judged inappropriate for this study by physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Suzuki |
Organization
Gunma University
Division name
Urology
Zip code
Address
3-39-22 Showa-machi, Maebashi
TEL
(027)220-8300
kazu@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidemasa Kawamura |
Organization
Gunma University
Division name
Heavy ion medical center
Zip code
Address
3-39-22 Showa-machi, Maebashi
TEL
027-220-8378
Homepage URL
kawa@gunma-u.ac.jp
Sponsor or person
Institute
Working group of heavy ion therapy for genitourinary tumor, Gunma university
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Check the symptoms, laboratory tests, radiological tests and QOL scores periodically.
Management information
Registered date
| 2015 | Year | 03 | Month | 10 | Day |
Last modified on
| 2017 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019421
